naa a22 4500 510763995 CHVBK 20180411083150.0 cr unu---uuuuu 180411e20130401xx s 000 0 eng 10.1007/s12094-012-0915-y doi (NATIONALLICENCE)springer-10.1007/s12094-012-0915-y Multicenter phase II clinical trial of preoperative capecitabine with concurrent radiotherapy in patients with locally advanced rectal cancer [Elektronische Daten] [Manuel de las Heras, Fernando Arias, Rosario del Moral-Avila, Jaime Gómez-Millán, Encarnación Jiménez, Amadeo Wals, Jose Tisaire, Ma Alcantara] Introduction: To assess pathologic complete response, sphincter preservation rates and toxicity profile of preoperative chemoradiation with capecitabine in resectable locally advanced rectal cancer. Materials and methods: Fifty-eight patients from six Spanish centers were included (March 2004 to June 2005) with histological/cytological diagnosis of locally advanced rectal cancer, age between 18 and 80years, ECOG 0-2, adequate bone marrow, renal and hepatic functions. Prior chemotherapy/radiotherapy was not allowed. Preoperative treatment was capecitabine 825mg/m2 bid concomitant to radiotherapy (45+5.4Gy boost over 5.5weeks). Surgery was performed 4-8weeks after completion of chemoradiotherapy. Results: Fifty-eight patients were enrolled in this study: 60.3% males, median age of 64.5 (30.9-78.7)years, 28.6% with ECOG 0 and 71.4% with ECOG 1. Median distance of tumor from the anal verge was 7 (1-12)cm. Fifty-two (89.6.%) patients completed preoperative chemoradiotherapy. Primary tumor and node downstaging occurred in 61.1 and 69.6% of patients, respectively. Surgery was performed in 55 patients (94.8%): 80% had negative lymph nodes and 72.7% underwent sphincter-preserving procedures. A pathologic complete response was observed in 10.5% (95% CI 2.5-18.5) of the patients. Main grade I-II toxicities were leucopenia (43.1%), neutropenia (24.1%), anemia (36.2%), diarrhea (32.8%) and skin disorders (5.1%), from which diarrhea (6.9%), leucopenia (1.7%) and skin disorders (1.7%) reached grade III. There were no grade IV toxicities. Conclusions: Preoperative capecitabine-based chemoradiation is a well-tolerated and effective neoadjuvant treatment for locally advanced rectal cancer that achieves encouraging rates of tumor downstaging. Federación de Sociedades Españolas de Oncología (FESEO), 2012 Rectal cancer nationallicence Capecitabine nationallicence Chemoradiotherapy nationallicence Radiation nationallicence Neoadjuvant treatment nationallicence de las Heras Manuel Head of the Department Radiation Oncology, Hospital Clínico Universitario San Carlos, c/Profesor Martín Lagos, S/N, 28040, Madrid, Spain aut Arias Fernando Department Radiation Oncology, Hospital de Navarra, Pamplona, Spain aut del Moral-Avila Rosario Head of the Department Radiation Oncology, Hospital Virgen de las Nieves, Granada, Spain aut Gómez-Millán Jaime Radiation Oncology Department, Hospital Virgen de la Victoria, Malaga, Spain aut Jiménez Encarnación Head of Department Clinical Oncology, Hospital de Jerez, Jerez, Spain aut Wals Amadeo Radiation Oncology Department, Hospital Carlos Haya, Malaga, Spain aut Tisaire Jose Radiotherapy Service, Hospital de Alcazar, Grupo Imo. Alcazar de San Juan, Ciudad Real, Spain aut Alcantara Ma Radiation Oncology Department, Hospital Clínico San Carlos, Madrid, Spain aut Clinical and Translational Oncology Springer Milan 15/4(2013-04-01), 294-299 1699-048X 15:4<294 2013 15 12094 https://doi.org/10.1007/s12094-012-0915-y text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s12094-012-0915-y text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- de las Heras Manuel Head of the Department Radiation Oncology, Hospital Clínico Universitario San Carlos, c/Profesor Martín Lagos, S/N, 28040, Madrid, Spain aut NATIONALLICENCE 700 1- Arias Fernando Department Radiation Oncology, Hospital de Navarra, Pamplona, Spain aut NATIONALLICENCE 700 1- del Moral-Avila Rosario Head of the Department Radiation Oncology, Hospital Virgen de las Nieves, Granada, Spain aut NATIONALLICENCE 700 1- Gómez-Millán Jaime Radiation Oncology Department, Hospital Virgen de la Victoria, Malaga, Spain aut NATIONALLICENCE 700 1- Jiménez Encarnación Head of Department Clinical Oncology, Hospital de Jerez, Jerez, Spain aut NATIONALLICENCE 700 1- Wals Amadeo Radiation Oncology Department, Hospital Carlos Haya, Malaga, Spain aut NATIONALLICENCE 700 1- Tisaire Jose Radiotherapy Service, Hospital de Alcazar, Grupo Imo. Alcazar de San Juan, Ciudad Real, Spain aut NATIONALLICENCE 700 1- Alcantara Ma Radiation Oncology Department, Hospital Clínico San Carlos, Madrid, Spain aut NATIONALLICENCE 773 0- Clinical and Translational Oncology Springer Milan 15/4(2013-04-01), 294-299 1699-048X 15:4<294 2013 15 12094 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer